The long-term alliance including the near-term projects from Otsuka and the earlier stage psychiatric disorder portfolio from Lundbeck enhances both companies’ portfolios of new medical offerings covering all aspects of severity in the treatment of patients suffering from psychotic, mood and behavioural disorders. In addition, this collaboration agreement will accelerate the development of Lundbeck’s most advanced schizophrenia projects.
“We are very pleased to have entered into this collaboration with Otsuka. With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with exciting and unique treatments in an area of high unmet needs,” said Ulf Wiinberg, President & Chief Executive Officer at Lundbeck. “This collaboration further strengthens our US platform and allows us to be introduced with the US psychiatry community already in 2013.”
“We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialisation agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business,” said Dr. Taro Iwamoto, President and Representative Director, Otsuka. “Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximise the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them in Europe, South America, Oceania, the BRIC countries and other countries around the world. Our collaboration will lead to the next generation of innovation by developing Lundbeck’s three new compounds.”
The alliance is a sales and cost share agreement. Under the terms of the agreement, Lundbeck will make an upfront payment upon signing of USD 200 million (approximately DKK 1.1 billion).
Otsuka will receive up to approximately USD 1.4 billion (approximately DKK 7.6 billion) in total from Lundbeck in upfront payment and development and regulatory milestone payments. Including sales milestones, Lundbeck will pay up to approximately USD 1.8 billion (approximately DKK 9.7 billion) to Otsuka. Both companies will share the sales as well as development and commercialisation costs based on the agreement.
Lundbeck is granted co-development and co-commercialisation rights to aripiprazole depot formulation and OPC-34712 in North and Latin America, Europe, Australia and some other countries. With the comparable efficacy and safety profile to already marketed aripiprazole formulations, aripiprazole depot formulation has been developed to reduce the chance of reoccurrence of symptoms for the patients who sometimes forget to take their medication as well as to enhance the convenience of medication with a once monthly dosing. The New Drug Application (NDA) for aripiprazole depot formulation is expected soon to be submitted to the US Food and Drug Administration (FDA), and Lundbeck expects that the Marketing Authorisation Application (MAA) is to be submitted in Europe during 2013.
OPC-34712 is a novel investigational psychotherapeutic compound developed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia). The compound has broad activity across multiple monoamine systems and exhibits reduced partial agonist activity at D2 dopamine receptors and enhanced affinity for specific serotonin receptors. OPC-34712 has entered into clinical phase III trial for schizophrenia and adjunctive treatment of major depressive disorder (MDD).
Under the terms of the agreement, Otsuka has an option to enter into co-development and co-commercialisation of up to three early stage compounds in Lundbeck’s R&D pipeline in certain geographical regions. The three compounds to be included in this collaboration are under discussion between Lundbeck and Otsuka.
Otsuka brings a strong presence in the North American and Asian central nervous system (CNS) markets, and Lundbeck compliments their position with a strong presence in Europe, Canada and Latin America. Combined, both companies reach most of the global CNS market.
Lundbeck’s and Otsuka’s shared vision
Otsuka started its business from Naruto City, Shikoku Island, Japan in 1921 and Lundbeck began its business in Copenhagen, Denmark in 1915. Both companies will collaborate for the benefit of patients with mental disorders and together pursue a world-class partnership in the field of CNS disorders.
At a time when many pharmaceutical companies have experienced challenges in bringing new CNS therapies to market, Otsuka and Lundbeck will take a different—and true to their entrepreneurial cultures—unconventional approach to delivering new treatment options. Both companies are committed to creating truly valuable drugs that benefit patients and their families.
Otsuka began its research and development efforts in the CNS area in the 1970s. Abilify® (aripiprazole), Otsuka’s top-selling CNS drug, was the result of a quarter of a century of commitment, followed by a successful collaboration with Bristol-Myers Squibb Company, which remains, and to which Otsuka remains fully committed. Abilify® is currently marketed in more than 65 countries and regions. The net sales of Abilify® in the fiscal year 2010 were approximately USD 4.5 billion (approximately DKK 24 billion) and is now one of the top three products among anti-psychotic agents worldwide[1]. Otsuka has a portfolio of psychiatric and neuroscience products in development for its next contribution to patients worldwide.
Lundbeck markets a number of different pharmaceuticals for the treatment of CNS disorders. The most recently launched compounds include: Cipralex®/Lexapro® (depression), the best selling product of the company with the global sales of approximately USD 4 billion (approximately DKK 22 billion); Ebixa® (Alzheimer’s disease); Azilect® (Parkinson’s disease); Xenazine® (chorea associated with Huntington’s disease); Serdolect® (schizophrenia); and Sabril® (epilepsy).
Both companies share similarities in their corporate cultures including the focus on truly innovative approaches, taking unconventional paths to drug discovery and commercialisation, and sharing the belief that doing so eventually leads to innovation.
Financial considerations of the deal
The alliance is a sales and cost share agreement. Under the terms of the agreement, Lundbeck will make an upfront payment upon signing of USD 200 million (approximately DKK 1.1 billion).
Otsuka will in total receive approximately USD 1.4 billion (approximately DKK 7.6 billion) from Lundbeck as upfront payment and development and regulatory milestone payments. Including sales milestones Lundbeck will pay up to approximately USD 1.8 billion (approximately DKK 9.7 billion) to Otsuka. Both companies will share the sales as well as development and commercialisation costs based on the agreement.
For aripiprazole depot formulation, Lundbeck will obtain 50% of net sales in Europe (EU5 and the Nordic countries) and Canada and 20% of net sales in the US from Otsuka. The cost incurred for the development and promotion will be shared in the same ratio. Otsuka holds the rights in many of the Asian countries including Japan, as well as Turkey and Egypt. For the remaining markets in the Lundbeck territories, Lundbeck will market the compound and Otsuka will supply the bulk at a price agreed upon as a percentage of sales.
For OPC-34712, Lundbeck will obtain 50% of net sales in Europe (EU5 and the Nordic countries) and Canada and 45% of net sales in the US from Otsuka. The cost incurred for the promotion will be shared in the same ratio. Otsuka holds the rights in many of the Asian countries including Japan, Turkey and Egypt. For the remaining markets in the Lundbeck territories, Lundbeck will market the compound, and Otsuka will supply the bulk at a price agreed upon as a percentage of sales. For the development costs of OPC-34712, Otsuka will be responsible up to a certain amount and equally share the costs with Lundbeck afterwards.
In co-commercialisation countries, the parties will share sales efforts and costs in accordance with the territory split. In the US, Canada, EU5 and the Nordic countries, Otsuka will book all sales. In the rest of Europe and the world, excluding many of the Asian countries, Turkey and Egypt, Lundbeck will book all sales and take full responsibility for commercialisation. Otsuka will retain the rights to participate in the co-development and co-marketing when it establishes a sales organisation in Lundbeck’s territory.
In November 2010, Lundbeck provided its long-term floor guidance. According to this guidance, Lundbeck expects to generate a minimum annual revenue and EBIT of DKK 14 billion and DKK 2 billion, respectively, in the period 2012-14. Following the co-commercialisation agreement with Otsuka, Lundbeck faces increased costs in connection with commercialisation of aripiprazole depot formulation as well as development cost for OPC-34712. Lundbeck remains committed to exceed the long-term floor guidance.
Lundbeck expects to continue its strong cash flow generation, and in the period 2012-2014 plans to pay out a dividend in the upper end of the payout target of 25-35%.
About aripiprazole depot formulation
Aripiprazole depot formulation is a sterile, lyophilized cake that when reconstituted with sterile water for injection, forms an injectable suspension. This formulation has been evaluated as a once-monthly injection for the maintenance treatment of schizophrenia.
Otsuka’s Aripiprazole Intramuscular Depot Study in Schizophrenia-US is a phase III clinical study of the depot formulation of aripiprazole that was designed to evaluate the efficacy, safety and tolerability of the intramuscular formulation as a maintenance treatment in patients with schizophrenia. The US registration study (31-07-246) was a multicentre, randomised, double-blind, placebo-controlled study, originally scheduled for a 52 week duration, which incorporated an interim analysis after achievement of 50% of the 125 events needed to complete the study. This interim analysis was conducted in June 2010, and the independent data monitoring committee determined that the interim analysis met the established termination criteria and recommended that the study be stopped.
About OPC-34712
OPC-34712 is a novel investigational psychotherapeutic compound developed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia). The compound has broad activity across multiple monoamine systems and exhibits reduced partial agonist activity at D2 dopamine receptors and enhanced affinity for specific serotonin receptors. OPC-34712 has entered into clinical phase III trial for schizophrenia and adjunctive treatment of MDD.
About Otsuka
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has business operations in 23 countries and regions around the world, with consolidated sales of JPY 1,090.2 billion for fiscal year 2010.
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at disorders such as depression and anxiety, schizophrenia, insomnia, epilepsy and Huntington’s, Alzheimer’s and Parkinson’s diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of the world’s leading pharmaceutical companies working with brain disorders. In 2010, the company’s revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD 2.6 billion).
Source: http://www.worldpharmanews.com/lundbeck/1862-lundbeck-and-otsuka-pharmaceutical-sign-historic-agreement
Lundbeck and Otsuka Pharmaceutical sign historic agreement is a post from: Hadron blog
Exploring the Superconducting Transition in Ultra Thin Films is a post from: Hadron blog
Those tricks improve the properties of certain organic polymers that mimic the properties of traditional inorganic semiconductors and could make the polymers very useful in organic solar cells, light-emitting diodes and thin-film transistors.
Conductive polymers date back to the late 1970s when researchers Alan Heeger, Alan MacDiarmid and Hideki Shirakawa discovered that plastics, with certain arrangements of atoms, can conduct electricity. The three were awarded the 2000 Nobel Prize in Chemistry for the discovery.
Jeffries-EL, an Iowa State assistant professor of chemistry, is working with a post-doctoral researcher and nine doctoral students to move the field forward by studying the relationship between polymer structures and the electronic, physical and optical properties of the materials. They’re also looking for ways to synthesize the polymers without the use of harsh acids and temperatures by making them soluble in organic solvents.
The building blocks of their work are a variety of benzobisazoles, molecules well suited for electrical applications because they efficiently transport electrons, are stable at high temperatures and can absorb photons.
And if the polymers are lacking in any of those properties, Jeffries-EL and her research group can do some chemical restructuring.
“With these polymers, if you don’t have the properties you need, you can go back and change the wheel,” Jeffries-EL said. “You can change the chemical synthesis and produce what’s missing.”
That, she said, doesn’t work with silicon and other inorganic materials for semiconductors: “Silicon is silicon. Elements are constant.”
The National Science Foundation is supporting Jeffries-EL’s polymer research with a five-year, $486,250 Faculty Early Career Development grant. She also has support from the Iowa Power Fund (a state program that supports energy innovation and independence) to apply organic semiconductor technology to solar cells.
The research group is seeing some results, including peer-reviewed papers over the past two years in Physical Chemistry Chemical Physics, Macromolecules, the Journal of Polymer Science Part A: Polymer Chemistry, and the Journal of Organic Chemistry.
“This research is really about fundamental science,” Jeffries-EL said. “We’re studying the relationships between structure and material properties. Once we have a polymer with a certain set of properties, what can we do?”
She and her research group are turning to the molecules for answers.
“In order to realize the full potential of these materials, they must be engineered at the molecular level, allowing for optimization of materials properties, leading to enhanced performance in a variety of applications,” Jeffries-EL wrote in a research summary. “As an organic chemist, my approach to materials begins with small molecules.”
Chemist Designs New Polymer Structures for Use as ‘Plastic Electronics’ is a post from: Hadron blog
Under the terms of the deal, Baxter will pay $170 million in cash and up to $168 million in future sales-based milestone payments.
Prism Pharma’s antiarrhythmic agent — drugs that are used to suppress abnormal rhythms of the heart — Nexterone is approved by the U.S. Food and Drug Administration.
Baxter was the contract manufacturer for Nexterone premixed intravenous bag formulations and pre-filled syringes.
The deal, which is to close in the second quarter, is not expected to materially impact its 2011 results, Baxter said.
Baxter to acquire Prism Pharma for $338 mln is a post from: Hadron blog
The submission to the MHLW is based on the results of the global ROCKET AF study and the Phase III J-ROCKET AF study, which was run entirely in Japan. Both studies investigated rivaroxaban versus dose-adjusted warfarin in patients with non-valvular atrial fibrillation at risk of stroke. The J-ROCKET AF trial was conducted with a 15 mg dose of rivaroxaban once daily, in recognition of the Japanese guideline environment. Results of the J-ROCKET AF study are planned to be presented at an upcoming major scientific meeting.
As communicated in January 2011, rivaroxaban 20 mg once daily has previously been submitted for marketing authorization in stroke prevention in patients with atrial fibrillation in the EU and the US. These submissions were supported by data from the pivotal, global Phase III ROCKET AF trial that was presented at the American Heart Association (AHA) Congress in November 2010. About Rivaroxaban
Rivaroxaban is an oral anticoagulant that was invented in Bayer HealthCare’s Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. It has a rapid onset of action with a predictable dose response and high bioavailability, no requirement for coagulation monitoring, as well as a limited potential for food and drug interactions.
Rivaroxaban is marketed under the brand name Xarelto® for the prevention of venous thromboembolism (VTE) in adult patients following elective hip or knee replacement surgery. Xarelto® is approved in more than 100 countries worldwide and has been successfully launched in more than 80 countries by Bayer HealthCare.
The extensive clinical trial program supporting rivaroxaban makes it the most studied oral, direct Factor Xa inhibitor in the world today. In total, more than 65,000 patients are expected to participate in the rivaroxaban clinical development program evaluating the product in the prevention and treatment of a broad range of venous and arterial thromboembolic diseases, including VTE treatment and secondary prevention of acute coronary syndrome (ACS).
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.913 billion (2010), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries.
Bayer’s Rivaroxaban Submitted for Approval in Japan is a post from: Hadron blog
OrbusNeich Medical, Inc. (“OrbusNeich” or the “Company”), a designer, developer, manufacturer and marketer of innovative medical devices for the treatment of vascular diseases, today issued a statement regarding unsuccessful retaliatory litigation efforts by Boston Scientific Corporation (NYSE: BSX) against OrbusNeich in The Netherlands. In March 2009, OrbusNeich filed a lawsuit in the United States asserting claims against Boston Scientific for patent infringement, breach of contract and for misappropriation of trade secrets related to the Boston Scientific Liberte and TAXUS Liberte branded stents. In April 2010, OrbusNeich expanded its lawsuit to include a newly granted patent, the “Stent with Helical Elements.” The suit seeks unspecified monetary damages and injunctive relief in connection with its claims. Boston Scientific filed its retaliatory lawsuit against OrbusNeich for alleged patent infringement by OrbusNeich’ Evolution 2 catheter in the Netherlands in November 2009.
Following is the Company’s statement:
Last month, the District Court of The Hague ruled that Boston Scientific’s patent for a “balloon catheter with distal guide wire lumen” had been revoked in the Netherlands for lack of inventive step in a previous decision of the District Court in a case against Medinol in September 2003. The District Court ruled that Boston Scientific’s patent must be considered as being revoked and that no injunction can be granted on the basis of this patent, unless and until the revocation decision by the District Court in the case against Medinol is set aside by the Court of Appeals of The Hague in the appeal proceedings against the revocation decision in that case. The District Court stayed the proceedings until a final and conclusive decision is rendered in the appeal proceedings against the revocation decision in the Medinol case. Boston Scientific’s claim for a preliminary injunction pending the stay was denied, as the District Court decided that Boston Scientific lacked an urgent interest, as Boston Scientific had already been aware of OrbusNeich’ catheter for many years.
We are pleased with the District Court of The Hague’s recent decision and we are confident in the Court of Appeals of The Hague reaching the same conclusion should Boston Scientific initiate the appeal. Considering Boston Scientific’s patent wasn’t valid when they filed suit, we believe their case is without merit and, consistent with their past business practices, is simply an effort to wear down OrbusNeich by forcing the Company to spend significant time, money and resources in defending the case. Further, we see this as an attempt to distract the marketplace from OrbusNeich’s pending patent infringement and theft of trade secret case against Boston Scientific in the United States. OrbusNeich is committed to fighting Boston Scientific to protect its proprietary technology and to enforce its patent rights.
Regarding our ongoing infringement and theft of trade secret claims against Boston Scientific in the United States District Court for the District of Massachusetts, we remain confident in our case and look forward to its advancement.
Source: http://www.prnewswire.com/news-releases/orbusneich-issues-statement-on-boston-scientifics-unsuccessful-retaliatory-litigation-efforts-in-the-netherlands-111107439.html
OrbusNeich Issues Statement on Boston Scientific’s Unsuccessful Retaliatory Litigation Efforts in the Netherlands is a post from: Hadron blog
Hsinchu-based Industrial Technology Research Institute (ITRI, 工研院), which is supervised by the nation’s Ministry of Economic Affairs, filed four lawsuits against LG Electronics. The complaints were submitted on Nov. 26 in federal court in Tyler, Texas.
ITRI, which was founded in 1973 “to strengthen the technological competitiveness of Taiwan” through research and development of new companies, claims LG Electronics is infringing on patents, including 15 related to LCD televisions and two for mobile phones. Seoul-based LG is the second-biggest TV maker.
Unless LG Electronics is barred from using the inventions, ITRI “will suffer additional irreparable harm for which there is no adequate remedy at law and impairment of the value of its patent rights,” the Taiwanese institute said in each of the complaints.
The institute is also seeking compensation for the unauthorized use of its technology.
LG Electronics, together with Nokia Oyj and chipmakers including STMicroelectronics NV, was also sued by the California Institute of Technology (Caltech) for allegedly infringing its patents.
Caltech, in a complaint filed on Nov. 24 in federal court in Los Angeles, lists nine patents pertaining to camera technology that it says LG Electronics and Nokia phones, as well as phones made by Seoul-based Pantech Co, infringe. The research university, based in Pasadena, California, seeks unspecified damages for willful infringement.
Source: http://www.taipeitimes.com/News/biz/archives/2010/12/02/2003489897
Taiwan’s ITRI takes LG to court claiming patent infringement is a post from: Hadron blog
RIM filed a statement of claim in Federal Court this week against Kik Interactive Ltd., a small Waterloo, Ont.-based software firm responsible for Kik Messenger, a smart-phone application that lets users instantly send messages to one another on BlackBerrys, iPhones and mobile devices running Google’s Android operating system.
In the month since its launch, Kik Messenger has amassed more than two million users. Two weeks after Kik’s software hit the BlackBerry app store, however, RIM banned the application.
Now, the BlackBerry maker is arguing that Kik Messenger infringes on RIM’s own BlackBerry Messenger, an instant-messaging application that has proven to be wildly popular with BlackBerry users.
Ted Livingston, chief executive officer of Kik, was previously employed at RIM on three occasions, Research In Motion says in its statement of claim filed with the court. Following his employment at the BlackBerry maker, he quickly went about starting his own instant-messaging app, RIM says.
“Initially, to gain access to and integrate its applications with RIM’s BlackBerry infrastructure, the Defendant represented to RIM that it was developing a music-sharing device to integrate with the BlackBerry Messenger platform,” RIM alleges in its filing with the Federal Court in Toronto.
“Instead the Defendant created a cross-platform instant-messaging application for use with various smart-phone platforms.”
Although the core of RIM’s claim is that Mr. Livingston’s company infringed on RIM’s intellectual property rights, the court file also contains other claims. RIM further alleges that the Kik application, once installed on a BlackBerry, accessed a user’s personal information, such as contact lists, without the user’s consent.
“Kik unfairly benefited from its decision to unlawfully access and use the end users’ personal information as a means of driving the growth of its business,” RIM said in its statement of claim.
In a response posted on the KIK website, Mr. Livingston said: “The company I shared our entire plan with every step of the way, is suing us. I’m not afraid. I’m not surprised. But I am disappointed.”
Kik called RIM’s lawsuit unjustified, and plans to “vigorously defend” against it.
None of RIM’s allegations have been proved in court.
By some measures, Kik is one of the fastest-growing application developers ever, drawing more than two million users in a month. In comparison, PingChat, a similar cross-platform messaging app launched for the iPhone in late 2009 and for the BlackBerry and Android last summer, has 5.5 million users. That app has many of the same features as Kik, but doesn’t automatically go through a user’s address book to find other app users.
RIM’s BlackBerry Messenger boasts about 30 million users, and is frequently listed as the main factor contributing to new BlackBerry purchases by consumers. Unlike Kik and PingChat, however, BBM is not cross-platform: Only BlackBerry users can take advantage of it to communicate with other BlackBerry users.
For many consumers – especially teens and young adults – instant-messaging apps are quickly replacing text-messaging. The technology is seen as faster and less expensive than the traditional text message. Many smart-phone messaging apps also allow users to send multimedia, such as audio and video files.
“I think more people, especially the younger generation, have a need to communicate, and the quickness of messages is quite critical,” said Gary Fung, co-founder of Enflick, the company behind PingChat. “Sending e-mail just doesn’t cut it.”
Source: http://www.theglobeandmail.com/news/technology/rim-files-patent-suit-against-kik/article1820419/
RIM launches Kik instant-messaging patent suit is a post from: Hadron blog
Citing Mohan’s “deliberate and continuous” infringement and the fact that the case involved medical products, Judge Ann Montgomery held that a broad permanent injunction was required to prevent confusion and protect the public. The order prohibits Mohan from using any of the trademarks or designations 3M uses with its LITTMANN(R) stethoscopes, or any confusingly similar designations. The court also enjoined Mohan from selling ear tips that infringe a 3M patent which was the subject of an earlier order. Finally, the court ordered Mohan to pay 3M’s costs and attorneys’ fees.
“The LITTMANN brand is synonymous with outstanding quality and acoustic performance,” said Ingrid Blair, vice president, Patient Assessment, 3M. “While 3M takes infringement of any of its intellectual property very seriously, it is especially important that purchasers of health care products such as stethoscopes receive authentic products. We hope this ruling will not only put an end to Mr. Mohan’s deceptive activities, but will send a message to other infringers and counterfeiters that 3M will do whatever is necessary to assure that medical professionals can count on the authenticity, quality, and reliability of products bearing 3M trademarks.”
In the ruling, Judge Montgomery found that Mohan purposefully “used … counterfeit marks in conjunction with other marks that are confusingly similar to well-known LITTMANN marks” to attract purchasers to his websites and eBay and Amazon offers, and to deceive those purchasers into buying stethoscopes they mistakenly believed were from 3M, or were in some way endorsed or approved by 3M. Despite 3M’s repeated requests that he stop, Mohan not only continued but “intensified the infringing nature of his marks,” the order said. The court’s ruling also cited evidence of actual confusion among Mohan’s customers, as well as complaints by Mohan’s customers about the quality of his products.
The court also commented on the effect of these activities in the Internet environment, noting that “the quick and effortless nature of the Internet makes it particularly unlikely that online customers will avoid confusion through the exercise of due care.” “Within online stethoscope advertisements, the display of marks identical to 3M’s … marks could lead even a careful medical professional familiar with stethoscopes to believe [Mohan's] stethoscopes are affiliated with the LITTMANN brand,” the court found.
The court further found that “[Mohan's] stethoscopes are of significantly lower quality than LITTMANN stethoscopes,” notwithstanding his claims that they “match[ed] the quality of the premium brand.” Noting that “LITTMANN stethoscopes are well known among medical professionals for superior acoustical quality,” the court concluded that “medical professionals who mistakenly believe [Mohan's] stethoscopes have acoustical performance quality equal to LITTMANN stethoscopes may misdiagnose or fail to diagnose their patients.”
Source:- http://www.marketwatch.com/story/judge-rules-in-favor-of-3m-in-trademark-and-patent-infringement-lawsuit-against-internet-distributor-of-stethoscopes-2010-12-01?reflink=MW_news_stmp
Judge Rules in Favor of 3M in Trademark and Patent Infringement Lawsuit Against Internet Distributor of Stethoscopes is a post from: Hadron blog
Nov. 19 — Smith & Nephew Plc, Europe’s biggest maker of shoulder and knee implants, infringed a patent for Kinetic Concepts Inc.’s severe-wound treatments, a U.K. appeals court said.
Pumps and canisters in Smith & Nephew’s Renasys EZ and Renasys GO devices infringed Kinetic’s patent in the U.K., the Court of Appeal ruled in London yesterday. The patents cover technology for using a vacuum-sealed film to treat wounds.
The ruling is the latest in a long-running dispute between Smith & Nephew and San Antonio-based Kinetic over devices that reduce infection and promote tissue growth in wounds. Related lawsuits over the devices have played out in the U.S., France, Germany and Australia.
“This isn’t just a victory for KCI, it is also a victory for patients and the health-care community,” Mike Genau, global president of Kinetic’s active-healing solutions unit, said in a statement.
Smith & Nephew, based in London, infringed Kinetic’s so- called ‘950 patent by selling its GO system canisters, while it didn’t infringe the company’s so-called ‘504 patent with the system, the three-judge panel ruled.
Another U.K. court in May 2009 ruled that most of Kinetic’s patent claims over Smith & Nephew’s foam were invalid. In that case, seven of 10 U.K. patent claims were thrown out. The ruling was upheld after Kinetic appealed.
Justine McIlroy, a spokeswoman for Smith & Nephew, declined to comment.
The U.S. case started in 2007, when Kinetic and Wake Forest University, which licensed the technology to the company, sued Bluesky Medical Corp., now owned by Smith & Nephew.
A federal jury in Texas in March 2009 found Kinetic suffered more than $900,000 in lost profits and said its patents were valid. Last month, the same court overturned the verdict and ruled that KCI’s patents were invalid, Smith & Nephew said in an Oct. 19 statement.
The U.K. case is KCI Licensing Inc. v. Smith & Nephew Plc, High Court of Justice, Chancery Division, HC09C02624.
J&J, U.S. Sue Mylan and Lupin to Block Copy of HIV Drug
Johnson & Johnson’s Tibotec unit and the U.S. government separately sued Mylan Inc. and Lupin Ltd. to prevent sales of a generic version of the HIV medicine Prezista.
Mylan and Lupin are each seeking U.S. Food and Drug Administration approval to sell a copy of the medicine, known by the compound name darunavir ethanolate. The U.S. and University of Illinois claim a generic would infringe a patent they own that expires in 2019, according to a complaint filed Nov. 15 in federal court in Newark, New Jersey. Tibotec said in its lawsuit that Mylan and Lupin would violate a patent expiring in 2026.
U.S. sales of Prezista increased 35 percent to $290 million in the first nine months of this year, making it one of New Brunswick, New Jersey-based J&J’s fastest-growing new drugs. Globally, sales reached $621 million, the company said Oct. 19. The pill, approved by U.S. regulators in 2006, is in a family known as protease inhibitors, designed to block infected cells from making new copies of HIV.
The government- and university-owned patent 7,470,506 issued in 2008, is for a way to detect if the virus has become resistant to treatment and to prevent it from developing such drug resistance. It was licensed exclusively to Tibotec, according to the government complaint. Tibotec’s patent 7,700,645 is for a method of formulating the compound so it’s more stable and effective.
Michael Laffin, a spokesman for Canonsburg, Pennsylvania- based Mylan, said the company had no comment. Officials with Lupin, based in Mumbai, didn’t immediately return a message seeking comment.
The lawsuit is standard under federal drug law to clarify patent rights while the FDA is considering applications.
Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2010/11/19/bloomberg1376-LC3RIS0YHQ0X01-3LD7SNH8FP3AOFOQBL3JCSKO2M.DTL#ixzz160LK2Xeh
Smith & Nephew, Nokia, J&J: Intellectual Property is a post from: Hadron blog
is a post from: Hadron blog
Sun said it received tentative approval on tablets of 5 milligrams, 10 milligrams, 20 milligrams, and 40 milligrams. Because the Food and Drug Administration decision is tentative, Sun cannot yet sell its version of Crestor. The patents supporting Crestor, or rosuvastatin calcium, begin expiring in 2016.
Crestor was first approved in 2003 and is one of AstraZeneca’s best selling products. U.S. sales of Crestor totaled $1.26 billion in the first half of 2010 and $2.73 billion worldwide. AstraZeneca has filed patent infringement lawsuits against Sun and several other companies who are hoping to market generic versions of Crestor.
Sun is based in Mumbai, India, and AstraZeneca is based in London.
Source:-http://www.canadianbusiness.com/markets/market_news/article.jsp?content=D9IHM66G0
Sun Pharma says its received tentative approval for generic Crestor, but can’t sell drug is a post from: Hadron blog
Source:- http://ibnlive.in.com/generalnewsfeed/news/nycomed-seeks-damages-from-sun-pharmaceuticals-teva/363278.html
Nycomed seeks damages from Sun Pharmaceuticals, Teva is a post from: Hadron blog
Trimeris is a biopharmaceutical company, while HLRL is a Switzerland-based developer and manufacturer of diagnostic and therapeutic products, HLRI is a prescription drug unit of the Roche Group and operates as a research-oriented pharmaceutical company and Novartis is a manufacturer of flu vaccines and operates meningococcal, pediatric and travel vaccine franchises. Trimeris, HLRI and Novartis are based in the US.
Under the terms of the settlement agreement, Roche and Trimeris collaboration will continue to sell FUZEON under a license to Novartis’ US patent No. 7,285,271 B1. In exchange for the grant of this license, Roche and Trimeris have agreed to pay royalties to Novartis on net sales of FUZEON of one and 1.5% on sales occurring in the US and Canada in a calendar year, and 1% on sales outside of the US and Canada in a calendar year. The royalty rate increases to 3% in the US and Canada and 1.5% in the rest of the world on any portion of FUZEON sales in excess of $50 million in the relevant region in a calendar year. Roche and Trimeris will share responsibility for payment of these royalties equally.
In addition, pursuant to the terms of the settlement, Trimeris will make an immediate payment to Novartis in the amount of approximately $2.45 million representing Trimeris’ 50% share of back royalties on sales of FUZEON through March 31, 2010. Trimeris will pay an additional $0.13 million to Novartis no later than October 31, 2010 representing Trimeris’ 50% share of royalties on the sale of FUZEON for the second quarter of 2010.
Source:- http://www.tradingmarkets.com/news/stock-alert/nvs_trms_trimeris-and-roche-settle-patent-infringement-suit-with-novartis-vaccines-and-diagnostics-for-fuzeon-1195687.html
Trimeris and Roche settle patent infringement suit with Novartis Vaccines and Diagnostics for FUZEON is a post from: Hadron blog
The lawsuit was dismissed late Tuesday by a judge in the U.S. District Court for the Southern District of New York, who ruled that Bayer’s patent fails to include an FDA-approved use for Yasmin.
Earlier this month, the FDA granted Watson approval for an Abbreviated New Drug Application (ANDA) for Zarah, which is the generic Yasmin equivalent. Bayer attempted to prevent Watson from filing the request, but a court denied that motion.
Bayer is currently involved in a similar lawsuit over generic Yaz, which is a lower dose version of the Yasmin birth control pill. Earlier this summer, Teva Pharmaceuticals introduced Gianvi, a Yaz generic version, which Bayer alleges violated an agreement between the two companies, as well as patent protections that should have prevented the introduction of a generic Yaz until 2014.
Yaz and Yasmin both contain a new “fourth generation” progestin, known as drospirenone, which is unique to these birth control pills and their generic equivalents. However, drospirenone has been cited as the likely cause of an increased risk of health problems from Yaz and Yasmin, such as strokes, heart attacks, pulmonary embolism, deep vein thrombosis, gallbladder disease and other potentially life-threatening injuries.
Thousands of women have already filed a Yaz birth control lawsuit or Yasmin birth control lawsuit against Bayer alleging that the drug maker failed to provide adequate warnings about the risk of side effects associated with the products. Since the label for Watson’s generic Yasmin will contain the same warnings as the name brand medication, the generic drug maker is likely to see a number of Zarah lawsuits filed if otherwise healthy women suffer injuries due to the inadequate warnings.
All federal Yasmin and Yaz litigation has been consolidated for pretrial proceedings as part of a multidistrict litigation (MDL), under Chief Judge David Herndon in the U.S. District Court for the Southern District of Illinois. It is likely that the generic Yasmin lawsuits would also be centralized as part of the same MDL.
Source: -http://www.aboutlawsuits.com/generic-yasmin-lawsuit-patent-dismissed-13094/
Generic Yasmin Lawsuit Over Patent Infringement Dismissed is a post from: Hadron blog